FDA Adverse Event Injury Summary report: N

ORMCO¿ ETCHFREE BONDING

MDR report key: 23149179 · Received September 25, 2025

Report

Report Number
2016150-2025-00004
Event Type
Injury
Date Received
September 25, 2025
Report Date
September 25, 2025
Manufacturer
ORMCO
Product Code
DYH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NJ, US
Reporter Occupation
DENTIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT EXPERIENCED AN ALLERGIC REACTION APPROXIMATELY 3-4 HOURS AFTER BONDING STAINLESS STEEL AND NICKEL TITANIUM BRACKETS USING THE ETCHFREE SYSTEM. THE PATIENT DEVELOPED ITCHY HIVES, THOUGH NO RESPIRATORY SYMPTOMS WERE REPORTED. HOWEVER, THE ATTENDING DOCTOR NOTED THAT, BASED ON PROFESSIONAL JUDGMENT, THE REACTION COULD HAVE ESCALATED TO A LIFE-THREATENING CONDITION. DURING THE BONDING PROCEDURE, ELASTOMERICS AND NITRILE GLOVES WERE USED IN CONJUNCTION WITH THE ETCHFREE SYSTEM. THE PATIENT SOUGHT MEDICAL ATTENTION FROM A PEDIATRICIAN ON THE DAY OF THE INCIDENT, FOLLOWED BY A VISIT TO URGENT CARE TWO DAYS LATER, WHERE THE DIAGNOSIS WAS CONFIRMED AS AN ALLERGIC REACTION. IN RESPONSE, THE DOCTOR AND THE PATIENT'S MOTHER DECIDED TO REMOVE THE BRACES CAREFULLY, USING: A HIGH-SPEED AIR PURIFIER WITH DUCTING HIGH-SPEED SUCTION FREQUENT INSTRUCTIONS FOR THE PATIENT TO SPIT OUT RESIDUAL MATERIAL. THE PATIENT WAS REFERRED TO AN ALLERGIST FOR COMPREHENSIVE ALLERGY TESTING OF DENTAL PRODUCTS TO IDENTIFY THE SPECIFIC ALLERGEN. TREATMENT INCLUDED ZYRTEC AND H1 BLOCKERS, WHICH LED TO SIGNIFICANT IMPROVEMENT. THE PATIENT HAS NOW FULLY RECOVERED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
298325 ORMCO¿ ETCHFREE BONDING ORMCO¿ ETCHFREE BONDING DYH ORMCO 740-0525 A213520

Patients

Seq Age Sex Outcome Treatment
1 11 YR Male Other